Table 2

Overview of miltefosine access issues by region

RegionYear first marketed/approvedAccess issuesSupply and delivery
Asia27 75 108 2002
  • Large minimum quantities to be eligible for the preferential price (one batch or min 200 000 caps)

  • Long lead time or delivery time and frequent stock-outs

  • Difficulties in forecasting demand

  • Tender system for national procurement: lack of details in the process for the manufacturer, programmes faced with lack of response

  • Low affordability for the government and NGO sector

Through national VL control programme
Africa106 NA*
  • The reluctance of the manufacturer to register the drug in endemic countries

  • Governments and end user/patients’ affordability

  • Limited evidence on its effectiveness in the continent

  • The dysfunctional or weak supply system

Usually brought in the country by NGOs or WHO
Europe31 78 2004
  • Only registered in Germany and very expensive (to buy directly from the manufacturer)

  • Can be accessed through the name-based patient compassionate programme

  • Liquid formulation for canine leishmaniasis is registered in most countries and widely used to treat pet dogs109

To be ordered directly from the company
North America31 86 97 2014
  • High cost and likely not covered by health insurance

  • Governments' and end users' affordability

Available through CDC as an off-label treatment for PAM
private market (producer price)*
Latin America53 110 2005
  • Registration has expired in many countries, no renewal sought by the company

  • High cost and limited availability outside research use in most of the countries in the region

Through MoH in coordination with PAHO
  • *Impavido is available in the USA since Knight Therapeutics provided licensing agreement to Profounda in 2015 (www.impavido.com).

  • CDC, Centres for Disease Control and Prevention; MoH, Ministry of Health; NGOs, non-governmental organisations; PAHO, Pan American Health Organization; PAM, primary amoebic meningoencephalitis; VL, visceral leishmaniasis.